Over-the-Needle Catheter Sleeve

ABSTRACT

The present disclosure is directed to an over-the-needle (OTN) catheter assembly having a sleeve configured thereon. The catheter includes a body having an outer diameter. The body also includes a proximal end and a distal end and defines a lumen extending from the proximal end to the distal end. A needle is configured within the lumen of the catheter and extends from the proximal end to the distal end. The sleeve is configured around a portion of the outer diameter of the catheter that passes through an insertion site of the catheter. Further, the sleeve includes a length extending from a first end to a second end and is configured to prevent the catheter from collapsing along the length of the sleeve. In addition, the sleeve is configured to prevent leakage from the insertion site of the catheter.

FIELD OF THE INVENTION

The present invention relates generally to the field of medicalcatheters and more particularly to over-the-needle (OTN) catheters.

BACKGROUND

Devices used to administer a fluid inside the anatomy of a patient arewell known. For example, hypodermic needles, catheters, and the like areoften used to deliver medication and other fluids to targeted siteswithin the body. In many instances, catheters are preferred because theycan deliver fluid to a particular site over a period of time. Sincecatheters are generally made of a flexible plastic material, a needle istypically used to insert the catheter within a patient. For example,certain catheters, generally referred to as “through-the-needle”catheters, often require stiff, hollow introducer needles for placementwithin the anatomy. Thus, the catheter can be inserted through theneedle after the needle is located at the targeted site. Typically, suchintroducer needles have sharp tips that may damage tissue and/or nervesduring their delivery into a body, thus causing discomfort for thepatient.

Another type of catheters, generally referred to as “over-the-needle”(OTN) catheters, include a catheter coaxially mounted onto a needle. Inthis type of catheter, the catheter and the needle may be inserted intoa patient together. Once the catheter and the needle are located at thetargeted site, the needle can be removed, leaving the catheter in place.Thus, OTN catheters can be purposely directed to an exact locationwithout the need to thread the catheter within a patient. Accordingly,OTN catheters have gained increased attention in regard to deliveringanesthetic medication, for example, for the purposes of nerve block.

It is desired to design OTN catheters with thin walls so as to decreasediscomfort to the patient and to minimize leakage at the insertion siteof the catheter. Such thin walls, however, can increase the catheter'ssusceptibility to kinking or collapsing when being inserted within apatient.

Accordingly, the present invention is directed to a sleeve for an OTNcatheter that addresses the aforementioned problems.

SUMMARY OF THE INVENTION

Objects and advantages of the invention will be set forth in part in thefollowing description, or may be obvious from the description, or may belearned through practice of the invention.

In certain aspects, the present invention relates to an over-the-needle(OTN) catheter assembly having a sleeve configured thereon. The catheterincludes a body having an outer diameter. The body also includes aproximal end and a distal end and defines a lumen extending from theproximal end to the distal end. A needle is configured within the lumenof the catheter and extends from the proximal end to the distal end. Thesleeve is configured around the portion of the outer diameter of thecatheter that passes through an insertion site of a patient. Further,the sleeve has a length extending from a first end to a second end thatis configured to prevent the catheter from collapsing along the lengthof the sleeve. The sleeve is also configured to minimize leakage fromthe insertion site of the catheter.

In one embodiment, the first end of the sleeve includes a tapered edge.Thus, the tapered edge is configured to minimize discomfort of thepatient at the insertion site of the catheter. In another embodiment,the sleeve may include a substantially linear portion and asubstantially angled portion. More specifically, the angled portion mayinclude at least one bend configured to prevent leakage from theinsertion site of the catheter, e.g. blood, medications, or similar. Incertain embodiments, the bend may include a substantially 90-degreeangle. In further embodiments, the bend may include any other suitableangle as well.

In additional embodiments, the length of the sleeve may range from about0.5 inches to about two inches, e.g. about one inch. In still furtherembodiments, the length of the sleeve may be less than 0.5 inches ormore than two inches. In another embodiment, the sleeve may beconstructed of a flexible material. For example, in various embodiments,the flexible material may include at least one of or a combination ofthe following: a rubber material, a silicone material, a polymericmaterial, an elastomeric material, or similar.

In another aspect, the present invention relates to a sleeve for anover-the-needle (OTN) catheter. The sleeve includes a body having alength extending from a first end to a second end. The body includes ahollow passageway extending from the first end to the second end. Thehollow passageway is configured to fit around a portion of an outerdiameter of the catheter. More specifically, the hollow passageway isconfigured to fit around the portion of the outer diameter of thecatheter that passes through an insertion site of a patient.

The body further includes a linear portion and an angled portion. Thus,the body is configured to prevent the catheter from collapsing along thelength of the sleeve and the angled portion is configured to preventleakage from the insertion site of the patient. It should be understoodthat the sleeve may also be configured with any of the additionalfeatures as described herein.

In yet another aspect, the present invention relates to a method forusing an over-the-needle catheter assembly to provide treatment to atargeted site within a patient. The method includes a step of providinga catheter having a proximal end and distal end, the catheter coaxiallymounted onto a needle. Another step includes inserting a sleeve aroundan outer diameter of the catheter, wherein the sleeve is configured toprevent the catheter from collapsing along a length of the sleeve. Stillanother step includes inserting simultaneously the catheter and theneedle into an insertion site of the patient until the distal end of thecatheter reaches the targeted site and a first end of the sleeve passesthrough the insertion site. The method also includes removing the needlefrom the catheter while the distal end of the catheter remains withinthe patient at the targeted site. Another step includes administering atreatment fluid to the targeted site via the catheter. It should beunderstood that the method may also include any of the additional stepsand/or features as described herein.

For example, in one embodiment, the method may further include bendingthe sleeve such that the sleeve has a linear portion and an angledportion. Thus, in another embodiment, after inserting simultaneously thecatheter and the needle into the insertion site of the patient, theangled portion may pass through the insertion site of the catheter so asto prevent leakage from the insertion site and the linear portion mayremain outside of the patient.

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the invention and, together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof, directed to one of ordinary skill in the art, is setforth in the specification, which makes reference to the appendedfigures, in which:

FIG. 1 illustrates a perspective view of one embodiment of an OTNcatheter assembly in accordance with aspects of the invention;

FIG. 2 illustrates a cross-sectional view of one embodiment of an OTNcatheter assembly in accordance with aspects of the invention;

FIG. 3 illustrates a perspective view of a sleeve for an OTN catheterassembly in accordance with aspects of the invention;

FIG. 4 illustrates a side, cross-sectional view of one embodiment of anOTN catheter assembly in accordance with aspects of the invention;

FIG. 5 illustrates a perspective view of one embodiment of an OTNcatheter assembly inserted into a patient in accordance with aspects ofthe invention; and

FIG. 6 illustrates a flow diagram of one embodiment of a method forusing an OTN catheter assembly to provide treatment to a targeted sitewithin a patient in accordance with aspects of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to one or more embodiments of theinvention, examples of the invention, examples of which are illustratedin the drawings. Each example and embodiment is provided by way ofexplanation of the invention, and is not meant as a limitation of theinvention. For example, features illustrated or described as part of oneembodiment may be used with another embodiment to yield still a furtherembodiment. It is intended that the invention include these and othermodifications and variations as coming within the scope and spirit ofthe invention.

The positional terms “proximal” and “distal” are used herein to orientthe various components relative to each other and to the patient.“Distal” refers to the direction that is closest to the wound site(e.g., the distal end of the catheter is the end oriented towards acatheter insertion site), and “proximal” refers to the oppositedirection (e.g., the proximal end of the catheter is typically insertedinto a catheter connector, which in turn is typically connected to afluid delivery device).

Generally, the present disclosure is directed to a sleeve for anover-the-needle (OTN) catheter assembly that prevents the catheter fromcollapsing along a length of the sleeve and minimizes leakage at aninsertion site of the catheter. The OTN catheter assembly includes acatheter coaxially mounted onto a needle. The catheter includes a bodyhaving an outer diameter. The body of the catheter has a proximal endand a distal end and defines a lumen extending from the proximal end tothe distal end. The sleeve is configured around the portion of the outerdiameter of the catheter that passes through the insertion site. Thus,the sleeve provides extra tubing that adds strength to the catheter soas to prevent the catheter from collapsing along a length thereof.Further, the sleeve typically includes a bend that minimizes leakage atthe insertion site of the catheter.

Referring now to the drawings, various embodiments of an over-the-needle(OTN) catheter assembly 10 according to the present disclosure areillustrated. For example, as shown in FIG. 1, the catheter assembly 10includes a catheter 14 having a body 20 with a proximal end 22 anddistal end 24 coaxially mounted onto a needle 12. In certainembodiments, the proximal end 22 may include a hub 16 configured thereonfor mating communication with a fluid delivery device (not shown). Asmentioned, the fluid delivery device may be any suitable device known inthe art, such as a pump, reservoir, syringe, or the like. Further, thehub 16 may have any conventional configuration, such as a Luer-lockfitting.

The body 20 of the catheter 14 defines a lumen 26 extending from theproximal end 22 of the catheter 14 to the distal end 24. Further, asshown in FIG. 2, the catheter 14 has an outer diameter 34 defined by anouter surface of the catheter wall. In accordance with aspects of thepresent disclosure, a sleeve 18 is configured around at least a portionof the outer diameter 34 of the catheter 14. More specifically, as shownin FIG. 3, the sleeve 18 includes a body 25 having a length L extendingfrom a first end 28 to a second end 30. It should be understood that thelength L of the sleeve 18 may be any suitable length so as to cover anysuitable length of the catheter 14. For example, in certain embodiments,the length L of the sleeve 18 ranges from about 0.5 inches to about twoinches, preferably about 1 inch. In additional embodiments, the length Lof the sleeve 18 may be less than 0.5 inches or more than two inches.

Referring particularly to FIG. 2, the body 25 of the sleeve 18 defines ahollow passageway 27 extending from the first end 28 to the second end30. As shown, the hollow passageway 27 is sized so as to receive theouter diameter 34 of the catheter 14. For example, as shown in FIG. 4,the hollow passageway 27 may have an inner diameter 31 that is slightlylarger than the outer diameter 34 of the catheter 14 such that thesleeve 18 can be easily slid over the catheter 14.

It should be understood that the sleeve 18 as described herein may beconstructed of any suitable, flexible material. For example, in certainembodiments, the sleeve 18 may be formed of a material that is rigidenough to keep its shape, yet flexible enough to curve with the shape ofthe catheter 14. More specifically, the sleeve 18 may constructed of aflexible material, such as plastic, rubber, a polymeric material,silicone, an elastomeric material, or any other suitable material.Further, in certain embodiments, the sleeve 18 may be constructed ofpolyisoprene, polyurethane, styrene butadiene, and/or any other suitableflexible material. As such, the sleeve 18 may be bendable, as isdiscussed in more detail below. In addition, the material of the sleeve18 may be designed such that the sleeve 18 easily slides along thecatheter 14 for example, by choosing materials that provide a low thecoefficient of friction therebetween.

Referring now to FIGS. 1 and 4-5, the sleeve 18 may be included as partof the OTN assembly 10 to prevent the catheter 14 from collapsing alonga length of the sleeve 18 and to prevent leakage at the insertion site42 of the catheter 14. Initially, the sleeve 18 may be included near thehub 16 of the catheter 14. Thus, the sleeve 18 is configured to slidealong the outer diameter 34 of the catheter 14 by a user such that theuser can place the sleeve 18 at any suitable location along the lengthof the catheter 14. For example, as shown in FIGS. 4 and 5, the sleeve18 is located closer to the distal end 24 of the catheter 14 than theproximal end 22 of the catheter 14. Thus, as the distal end 24 of thecatheter 14 is inserted into the patient, a user can move the sleevealong the outer diameter 34 of the catheter 14 such that it is locatedat the insertion site 42 of the catheter 14. In alternative embodiments,the sleeve 18 may be located closer to the proximal end 22 of thecatheter 14 than the distal end 24 of the catheter 14.

Referring to FIG. 5, the first end 28 of the sleeve 18 may be configuredto be easily inserted into the patient 44 at the insertion site 42. Morespecifically, in certain embodiments, the sleeve 18 may include atapered edge 32 to assist with inserting the sleeve 18 into a patient44. For example, as shown in FIG. 4, the inner and outer diameters 31,33 of the sleeve 18 generally define a thickness t therebetween. Thus,the tapered edge 32 generally tapers from the outer diameter 33 to theinner diameter 31 such that the thinnest portion of the tapered edge 32is slightly larger than the outer diameter 34 of the catheter 14.Accordingly, the tapered edge 32 may be easily inserted into theinsertion site 42 of the patient 44 along with the catheter 14 withoutincreasing discomfort to the patient.

In addition, as mentioned, the sleeve 18 can be constructed of aflexible and/or bendable material such that a user can bend the sleeve18 to create a linear portion 36 and an angled portion 38 as shown inFIG. 5. More specifically, the angled portion 38 may include a bend 40having a substantially 90-degree angle other than 90 degrees. In furtherembodiments, the bend 40 may have any suitable angle. For example, thebend 40 may have an angle less than 90 degrees or an angle greater than90 degrees. Thus, a user can locate the sleeve 18 in the desiredlocation along the length of the catheter 14 and then bend the sleeve 18to the desired angle. In one embodiment, for example, as user can slidethe sleeve 18 to a location near the insertion site 42 of the catheter14, bend the sleeve 18 to the desired angle, and then insert the firstend 28 of the sleeve 18 into the patient 44 such that the bend 40 islocated at the insertion site 42. Thus, the sleeve 18 (particularly thebend 40) helps to minimize leakage, e.g. blood, medications, etc., fromthe insertion site 42.

Referring now to FIG. 6, a flow diagram of one embodiment of a method100 for using an over-the-needle catheter assembly to provide treatmentto a targeted site within a patient is illustrated. As shown in theillustrated embodiment, the method 100 includes a step 102 of providinga catheter having a proximal end and distal end coaxially mounted onto aneedle. Another step 104 includes inserting a sleeve around an outerdiameter of the catheter. As mentioned, the sleeve is configured toprevent the catheter from collapsing along a length of the sleeve. Inadditional embodiments, the method 100 may also include bending thesleeve such that the sleeve has a linear portion and an angled portion.The method 100 also includes inserting simultaneously the catheter andthe needle into an insertion site of the patient until the distal end ofthe catheter reaches the targeted site and a first end of the sleevepasses through the insertion site (step 106). More specifically, incertain embodiments, the angled portion of the sleeve may be located atthe insertion site, such that a bend in the angled portion minimizesleakage from the insertion site. Once the catheter has been inserted andthe sleeve properly placed, the method 100 may also include removing theneedle from the catheter while the distal end of the catheter remainswithin the patient adjacent to the targeted site (step 108). A next step110 includes administering a treatment fluid to the targeted site viathe catheter. As mentioned, the sleeve provides strength to the catheteralong the length of the sleeve and includes a bend at the insertion sitethat minimizes leakage therefrom.

While the present invention has been described in connection withcertain preferred embodiments it is to be understood that the subjectmatter encompassed by way of the present invention is not to be limitedto those specific embodiments.

On the contrary, it is intended for the subject matter of the inventionto include all alternatives, modifications and equivalents as can beincluded within the spirit and scope of the following claims.

What is claimed is:
 1. An over-the-needle catheter assembly, comprising:a catheter comprising a body having an outer diameter, said bodycomprising a proximal end and a distal end, said body defining a lumenextending from said proximal end to said distal end; a needle configuredwithin the lumen of the catheter, said needle extending from saidproximal end to said distal end; and, a sleeve configured around aportion of said outer diameter of said catheter that passes through aninsertion site of a patient, said sleeve comprising a length extendingfrom a first end to a second end, wherein said sleeve is configured toprevent said catheter from collapsing along said length of said sleeve.2. The catheter assembly of claim 1, wherein said first end of saidsleeve comprises a tapered edge, said tapered edge configured to beinserted into the insertion site of the patient.
 3. The catheterassembly of claim 1, wherein said sleeve further comprises asubstantially linear portion and a substantially angled portion.
 4. Thecatheter assembly of claim 3, wherein said angled portion comprises atleast one bend configured to prevent leakage from the insertion site ofthe patient.
 5. The catheter assembly of claim 4, wherein said bendcomprises a substantially 90-degree angle.
 6. The catheter assembly ofclaim 1, wherein said length of said sleeve ranges from about 0.5 inchesto about two inches.
 7. The catheter assembly of claim 1, wherein saidsleeve further comprises a flexible material.
 8. The catheter assemblyof claim 7, wherein said flexible material further comprises at leastone of or a combination of the following: a rubber material, a siliconematerial, a polymeric material, or an elastomeric material.
 9. A sleevefor an over-the-needle catheter, said sleeve comprising: a body having alength extending from a first end to a second end, said body comprisinga hollow passageway extending from said first end to said second end,said hollow passageway configured to fit around a portion of an outerdiameter of the catheter that passes through an insertion site of apatient, said body further comprising a linear portion and an angledportion, said body configured to prevent the catheter from collapsingalong said length of said sleeve, said angled portion configured toprevent leakage from the insertion site of the patient.
 10. The sleeveof claim 9, wherein said first end of said sleeve comprises a taperededge, said tapered edge configured to be inserted into the insertionsite of the patient.
 11. The sleeve of claim 10, wherein said angledportion comprises at least one bend configured to prevent leakage fromthe insertion site of the patient.
 12. The sleeve of claim 11, whereinsaid bend comprises a substantially 90-degree angle.
 13. The sleeve ofclaim 9, wherein said length ranges from about 0.5 inches to about twoinches.
 14. The sleeve of claim 9, further comprising a flexiblematerial, said flexible material comprising at least one of or acombination of the following: a rubber material, a silicone material, apolymeric material, or an elastomeric material.
 15. A method for usingan over-the-needle catheter assembly to provide treatment to a targetedsite within a patient, the method comprising: providing a catheterhaving a proximal end and distal end, the catheter coaxially mountedonto a needle; inserting a sleeve around an outer diameter of thecatheter, wherein the sleeve is configured to prevent the catheter fromcollapsing along a length of the sleeve; inserting simultaneously thecatheter and the needle into an insertion site of the patient until thedistal end of the catheter reaches the targeted site and a first end ofthe sleeve is passes through the insertion site; removing the needlefrom the catheter while the distal end of the catheter remains withinthe patient adjacent to the targeted site; and administering a treatmentfluid to the targeted site via the catheter.
 16. The method of claim 15,wherein said first end of said sleeve comprises a tapered edge.
 17. Themethod of claim 15, further comprising bending the sleeve such that thesleeve has a linear portion and an angled portion.
 18. The method ofclaim 17, wherein, after inserting simultaneously the catheter and theneedle into the insertion site of the patient, the angled portion passesthrough the insertion site and the linear portion remains outside of thepatient, wherein the angled portion minimizes leakage from the insertionsite of the patient.
 19. The method of claim 18, wherein the angledportion comprises a substantially 90-degree bend.
 20. The method ofclaim 15, wherein the sleeve further comprises a flexible material,wherein the flexible material further comprises at least one of or acombination of the following: a rubber material, a silicone material, apolymeric material, or an elastomeric material.